Study Title:  Optimal Combination Therapy After Nevirapine Exposure (OCTANE). Alternate Title For The Study: NNRTI and PI-based ARV Treatment In Women With/Without Single-Dose NVP MTCT Prophylaxis

Sponsor : U.S. National Institute of Allergy and Infectious Diseases, Pharmacuetical support provided by Abbott Laboratories, Boehringer-IngelheimPharmaceuticals,Inc, Bristol- Myers Squibb,Gilead Sciences,Inc.

Name of PI :  Dr Tsungai Chipato 
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Study Summary

This study (A5208/OCTANE) seeks to compare the treatment responses to NNRTI-based regimens in women who have or have not received single-dose nevirapine (SD NVP) prophylaxis and to compare these responses to treatment responses to protease inhibitor (PI)-based regimens in the same patient populations. It is anticipated that this study will determine whether treatment responses to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens are compromised in women who have received prior SD NVP prophylaxis and will also provide insight into whether a PI-based regimen would fare better in this setting.

It is a phase III study comprising two randomized clinical trials (RCT) to be conducted concurrently.  Both trials will compare the virologic response to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (Arm 1A) versus protease inhibitor (PI)-based (Arm 1B) antiretroviral treatment (ART) in HIV-infected treatment-naïve women.

Trial 1 will evaluate the superiority of PI-based ART over NNRTI-based ART in women
with prior single dose (SD) nevirapine (NVP) prophylaxis for mother-to-child-
transmission (MTCT) of HIV.

Trial 2 will evaluate the equivalence of PI- and NNRTI-based ART in women with no
prior NVP exposure. 

640 HIV-infected, treatment-naïve women, with CD4+ count <200 cells/mm3 will be
enrolled across 8 sites in Southern Africa. These include sites in South Africa (3),
Uganda(1), Kenya(2), Botswana (1) and Zambia (1).

In Zimbabwe the study is being conducted at Parirenyatwa Hospital in Harare.
Approximately 130 women will participate in the study, 50 with prior receipt of SD NVP MTCT prophylaxis and 80 with no prior NVP exposure. About 60 participants have been enrolled after screening commenced in February 2006. Enrolled participants will be followed for up to 48 weeks while on ART.

Study Contact Information

Dr Nehemiah Nhando (Senior Research Medical officer)
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Elizabeth Dangaiso (Study Coordinator)
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Project Funders and Sponsors
A Collaborative, Multicenter Trial between the AIDS Clinical Trials Group ACTG) and the Division of AIDS (DAIDS)-Sponsored Networks
The National Institute of Allergy and Infectious Diseases
Pharmaceutical Support Provided by:
Abbott Laboratories
Boehringer Ingelheim Pharmaceuticals
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck & Co.